title: Design and rationale of a randomized trial comparing the Blalock-Taussig and right ventricle-pulmonary artery shunts in the Norwood procedure.
abstract: OBJECTIVE
  The initial palliative procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood procedure, remains among the highest risk procedures in congenital heart surgery. The classic Norwood procedure provides pulmonary blood flow with a modified Blalock-Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood procedure that uses a right ventricle-pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques.
  
  
  METHODS
  The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood procedure with either the right ventricle-pulmonary artery or modified Blalock-Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups.
  
  
  CONCLUSIONS
  This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.
authors.affiliation: University of Michigan Medical School, Ann Arbor, Michigan, USA. ohye@umich.edu
authors.forename: Richard G
authors.initials: RG
authors.lastname: Ohye
authors.forename: J William
authors.initials: JW
authors.lastname: Gaynor
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Ghanayem
authors.forename: Caren S
authors.initials: CS
authors.lastname: Goldberg
authors.forename: Peter C
authors.initials: PC
authors.lastname: Laussen
authors.forename: Peter C
authors.initials: PC
authors.lastname: Frommelt
authors.forename: Jane W
authors.initials: JW
authors.lastname: Newburger
authors.forename: Gail D
authors.initials: GD
authors.lastname: Pearson
authors.forename: Sarah
authors.initials: S
authors.lastname: Tabbutt
authors.forename: Gil
authors.initials: G
authors.lastname: Wernovsky
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Wruck
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Atz
authors.forename: Steve D
authors.initials: SD
authors.lastname: Colan
authors.forename: James
authors.initials: J
authors.lastname: Jaggers
authors.forename: Brian W
authors.initials: BW
authors.lastname: McCrindle
authors.forename: Ashwin
authors.initials: A
authors.lastname: Prakash
authors.forename: Michael D
authors.initials: MD
authors.lastname: Puchalski
authors.forename: Lynn A
authors.initials: LA
authors.lastname: Sleeper
authors.forename: Mario P
authors.initials: MP
authors.lastname: Stylianou
authors.forename: Lynn
authors.initials: L
authors.lastname: Mahony
mesh_terms: D006348:Cardiac Surgical Procedures / Q000379:methods* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D018610:Heart Bypass, Right / Q000379:methods / Q000401:mortality; D006352:Heart Ventricles / Q000002:abnormalities / Q000601:surgery*; D006801:Humans; D018636:Hypoplastic Left Heart Syndrome / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D011651:Pulmonary Artery / Q000601:surgery*; D011652:Pulmonary Circulation / Q000502:physiology; D012107:Research Design; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome